Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
NCT ID: NCT02604992
Last Updated: 2016-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
54 participants
INTERVENTIONAL
2015-11-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users
NCT02094599
Ph1 Marinol Interaction Study - Part 2 - 1
NCT00490269
A Bioavailability Study on Dronabinol
NCT03098940
Ph1 Marinol Interaction Study - Part 1 - 1
NCT00438139
Effects of Dronabinol (Oral THC) on Cannabis Use
NCT01394185
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (A,B,C)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Group 2 (B,C,A)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Group 3 (C,A,B)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Group 4 (C,B,A)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Group 5 (A,C,B)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Group 6 (B,A,C)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment A
Dronabinol oral solution, under fed conditions
Treatment B
Dronabinol oral capsule, under fed conditions
Treatment C
Dronabinol oral capsule, under fasted conditions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator
Exclusion Criteria
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
3. the analysis of results
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
INSYS Therapeutics Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neha Parikh
Role: STUDY_DIRECTOR
INSYS Therapeutics Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INS004-15-059
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.